BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 25001027 · Received April 27, 2026

    Report

    Report Number
    3005094123-2026-00193
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740121815
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: E1: ADDRESS 1: COMPLETE ADDRESS INFORMATION: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY CULLEN, M.R., AND LEE, G.R., ¿EVALUATION OF FREE THYROXINE AND HIGH SENSITIVITY CARDIAC TROPONIN DUPLICATE TESTING,¿ CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 2026; 64(4): EA78. DOI: 10.1515/CCLM-2026-0148, DESCRIBES THE USE OF ROUTINE DUPLICATE TESTING AS A RISK MANAGEMENT STRATEGY TO DETECT ANALYTICAL ERRORS IN ELEVATED ALINITY I FREE T4 RESULTS GENERATED BY THE ALINITY I PROCESSING MODULES. DUPLICATE TESTING WAS PERFORMED FOR ALL ELEVATED ALINITY I FREE T4 RESULTS >20 PMOL/L. RESULTS WERE ASSESSED USING A PREDEFINED ACCEPTABILITY CRITERION OF A >20% DIFFERENCE AT CONCENTRATIONS =20 PMOL/L. NINETY-TWO DUPLICATE PAIRS WERE ANALYZED, FROM WHICH ONLY ONE DEMONSTRATED AN ANALYTICAL ERROR (1.1%). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216089 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740121815

    Patients

    Seq Age Sex Outcome Treatment
    1